Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial
Single-cycle melphalan 200 mg/m and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, ran...
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| Vydané v: | Journal of clinical oncology Ročník 37; číslo 7; s. 589 |
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| Hlavní autori: | , , , , , , , , , , , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
| Vydavateľské údaje: |
United States
01.03.2019
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| ISSN: | 1527-7755, 1527-7755 |
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| Abstract | Single-cycle melphalan 200 mg/m
and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.
Patients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.
The study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.
Second AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population. |
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| AbstractList | Single-cycle melphalan 200 mg/m
and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.
Patients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.
The study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.
Second AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population. Single-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.PURPOSESingle-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved progression-free survival (PFS) and overall survival (OS) for transplantation-eligible patients with multiple myeloma (MM). We designed a prospective, randomized, phase III study to test additional interventions to improve PFS by comparing AHCT, tandem AHCT (AHCT/AHCT), and AHCT and four subsequent cycles of len, bortezomib, and dexamethasone (RVD; AHCT + RVD), all followed by len until disease progression.Patients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.PATIENTS AND METHODSPatients with symptomatic MM within 12 months from starting therapy and without progression who were age 70 years or younger were randomly assigned to AHCT/AHCT + len (n = 247), AHCT + RVD + len (n = 254), or AHCT + len (n = 257). The primary end point was 38-month PFS.The study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.RESULTSThe study population had a median age of 56 years (range, 20 to 70 years); 24% of patients had high-risk MM, 73% had a triple-drug regimen as initial therapy, and 18% were in complete response at enrollment. The 38-month PFS rate was 58.5% (95% CI, 51.7% to 64.6%) for AHCT/AHCT + len, 57.8% (95% CI, 51.4% to 63.7%) for AHCT + RVD + len, and 53.9% (95% CI, 47.4% to 60%) for AHCT + len. For AHCT/AHCT + len, AHCT + RVD + len, and AHCT + len, the OS rates were 81.8% (95% CI, 76.2% to 86.2%), 85.4% (95% CI, 80.4% to 89.3%), and 83.7% (95% CI, 78.4% to 87.8%), respectively, and the complete response rates at 1 year were 50.5% (n = 192), 58.4% (n = 209), and 47.1% (n = 208), respectively. Toxicity profiles and development of second primary malignancies were similar across treatment arms.Second AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population.CONCLUSIONSecond AHCT or RVD consolidation as post-AHCT interventions for the up-front treatment of transplantation-eligible patients with MM did not improve PFS or OS. Single AHCT and len should remain as the standard approach for this population. |
| Author | Vij, Ravi Krishnan, Amrita Nelson, Courtney Hari, Parameswaran Bashey, Asad Devine, Steven Landau, Heather Somlo, George Stadtmauer, Edward A Giralt, Sergio Knust, Kristin Qazilbash, Muzaffar H Gasparetto, Cristina Efebera, Yvonne Geller, Nancy McCarthy, Philip Pasquini, Marcelo C Shah, Nina Ganguly, Siddharta Brunstein, Claudio Vesole, David H Blackwell, Beth Horowitz, Mary M Koreth, John Vogl, Dan T |
| Author_xml | – sequence: 1 givenname: Edward A surname: Stadtmauer fullname: Stadtmauer, Edward A organization: 1 University of Pennsylvania, Philadelphia, PA – sequence: 2 givenname: Marcelo C surname: Pasquini fullname: Pasquini, Marcelo C organization: 2 Medical College of Wisconsin, Milwaukee, WI – sequence: 3 givenname: Beth surname: Blackwell fullname: Blackwell, Beth organization: 3 The Emmes Corporation, Rockville, MD – sequence: 4 givenname: Parameswaran surname: Hari fullname: Hari, Parameswaran organization: 2 Medical College of Wisconsin, Milwaukee, WI – sequence: 5 givenname: Asad surname: Bashey fullname: Bashey, Asad organization: 4 BMT Group of Georgia, Atlanta, GA – sequence: 6 givenname: Steven surname: Devine fullname: Devine, Steven organization: 5 The Ohio State University, Columbus, OH – sequence: 7 givenname: Yvonne surname: Efebera fullname: Efebera, Yvonne organization: 5 The Ohio State University, Columbus, OH – sequence: 8 givenname: Siddharta surname: Ganguly fullname: Ganguly, Siddharta organization: 6 University of Kansas Hospital, Kansas City, KS – sequence: 9 givenname: Cristina surname: Gasparetto fullname: Gasparetto, Cristina organization: 7 Duke University, Durham, NC – sequence: 10 givenname: Nancy surname: Geller fullname: Geller, Nancy organization: 8 National Heart, Lung, and Blood Institute, Rockville, MD – sequence: 11 givenname: Mary M surname: Horowitz fullname: Horowitz, Mary M organization: 2 Medical College of Wisconsin, Milwaukee, WI – sequence: 12 givenname: John surname: Koreth fullname: Koreth, John organization: 9 Dana-Farber Cancer Institute, Boston, MA – sequence: 13 givenname: Kristin surname: Knust fullname: Knust, Kristin organization: 3 The Emmes Corporation, Rockville, MD – sequence: 14 givenname: Heather surname: Landau fullname: Landau, Heather organization: 10 Memorial Sloan Kettering Cancer Center, New York, NY – sequence: 15 givenname: Claudio surname: Brunstein fullname: Brunstein, Claudio organization: 11 University of Minnesota, Minneapolis, MN – sequence: 16 givenname: Philip surname: McCarthy fullname: McCarthy, Philip organization: 12 Roswell Park Cancer Institute, Buffalo, NY – sequence: 17 givenname: Courtney surname: Nelson fullname: Nelson, Courtney organization: 3 The Emmes Corporation, Rockville, MD – sequence: 18 givenname: Muzaffar H surname: Qazilbash fullname: Qazilbash, Muzaffar H organization: 13 The University of Texas MD Anderson Cancer Center, Houston, TX – sequence: 19 givenname: Nina surname: Shah fullname: Shah, Nina organization: 14 University of California, San Francisco, San Francisco, CA – sequence: 20 givenname: David H surname: Vesole fullname: Vesole, David H organization: 15 Hackensack University, Hackensack, NJ – sequence: 21 givenname: Ravi surname: Vij fullname: Vij, Ravi organization: 16 Washington University, St Louis, MO – sequence: 22 givenname: Dan T surname: Vogl fullname: Vogl, Dan T organization: 1 University of Pennsylvania, Philadelphia, PA – sequence: 23 givenname: Sergio surname: Giralt fullname: Giralt, Sergio organization: 10 Memorial Sloan Kettering Cancer Center, New York, NY – sequence: 24 givenname: George surname: Somlo fullname: Somlo, George organization: 17 City of Hope, Los Angeles, CA – sequence: 25 givenname: Amrita surname: Krishnan fullname: Krishnan, Amrita organization: 17 City of Hope, Los Angeles, CA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30653422$$D View this record in MEDLINE/PubMed |
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| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Journal of clinical oncology |
| PublicationTitleAlternate | J Clin Oncol |
| PublicationYear | 2019 |
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| Snippet | Single-cycle melphalan 200 mg/m
and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved... Single-cycle melphalan 200 mg/m2 and autologous hematopoietic cell transplantation (AHCT) followed by lenalidomide (len) maintenance have improved... |
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| SubjectTerms | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bortezomib - administration & dosage Bortezomib - adverse effects Consolidation Chemotherapy Dexamethasone - administration & dosage Dexamethasone - adverse effects Disease Progression Female Hematopoietic Stem Cell Transplantation - adverse effects Hematopoietic Stem Cell Transplantation - mortality Humans Lenalidomide - administration & dosage Lenalidomide - adverse effects Maintenance Chemotherapy Male Melphalan - administration & dosage Middle Aged Multiple Myeloma - mortality Multiple Myeloma - pathology Multiple Myeloma - therapy Myeloablative Agonists - administration & dosage Progression-Free Survival Prospective Studies Remission Induction Reoperation Time Factors Transplantation, Autologous United States Young Adult |
| Title | Autologous Transplantation, Consolidation, and Maintenance Therapy in Multiple Myeloma: Results of the BMT CTN 0702 Trial |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/30653422 https://www.proquest.com/docview/2179400631 |
| Volume | 37 |
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